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Study of the Arachidonate 5-Lipoxygenase Enzyme in Affecting the Risk for Coronary Heart Disease

Primary Purpose

Coronary Heart Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

montelukast

Placebo

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring coronary heart disease, montelukast, inflammation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-Current hypertension (blood pressure > 140/90 mmHg) or current use of anti-hypertensive medications AND

Exclusion Criteria:

Current use of lipid-lowering medications
Current use of montelukast
Poorly controlled hypertension, where systolic blood pressure is greater than 160 or diastolic blood pressure is greater than 100
Use of steroid drugs, non-steroidal anti-inflammatory drugs or other anti-inflammatory medications in the two weeks prior to enrollment. (low dose aspirin ( < 325 mg) is OK, but indication must be cardiovascular)
Current recreational drug use
Other cardiovascular disease or previous cardiovascular event. These include:
history of angina pectoris
history of heart failure
presence of a cardiac pacemaker
history of myocardial infarction
previous revascularization procedure
history cerebrovascular disease including stroke and transient ischemic attack
Pregnancy or lactation
Diabetes mellitus
Lactose intolerance
Contraindications to montelukast therapy
Alcoholism
Known hepatic disease
Existing chronic obstructive pulmonary disease, asthma, allergic rhinitis
Active chronic immune, infectious, neoplastic or inflammatory diseases requiring therapy (such as active Hepatitis B, Hepatitis C, human immunodeficiency virus (HIV))
Immunosuppressant therapy or known immunosuppression due to disease high density lipoprotein (HDL) < 40 mg/dL (although this would be a risk factor for heart disease, because of preliminary data which indicates that montelukast may lower HDL levels, we will exclude patients with abnormally low HDL from study)
Other criteria at investigator discretion that are deemed to make the subject a poor candidate for the study

Sites / Locations

University of Florida Family Practice Medical Group Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Montelukast 10 mg

Arm Description

1 lactose-containing capsule daily for 1 month

1 montelukast 10 mg tablet (masked by capsule) daily for 1 month

Outcomes

Primary Outcome Measures

High-sensitivity C-reactive Protein

measured in a CLIA clinical laboratory facility (Quest Diagnostics, Tampa, FL)

Secondary Outcome Measures

High Density Lipoprotein (HDL)-Cholesterol

Lipid levels were determined at a clinical laboratory (Quest Diagnostics)

Full Information

NCT ID

NCT00379808

First Posted

September 20, 2006

Last Updated

June 7, 2012

Sponsor

University of Florida

Collaborators

American Heart Association

1. Study Identification

Unique Protocol Identification Number

NCT00379808

Brief Title

Study of the Arachidonate 5-Lipoxygenase Enzyme in Affecting the Risk for Coronary Heart Disease

Official Title

Role of the Arachidonate 5-Lipoxygenase Pathway in Coronary Heart Disease

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

July 2006 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

Collaborators

American Heart Association

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine whether a particular substance involved in inflammation, called leukotrienes, is involved in causing heart disease to occur or to progress.

Detailed Description

The focus of this study is to better understand why some adults develop heart disease and others do not. There are many known factors which play a role in causing heart disease, such as diet and lifestyle. Also, we know that inflammation, a process in the body which causes painful joints in arthritis or swelling at a site if injury, also contributes to heart disease. In particular, we will address whether leukotrienes, a component of inflammation, is involved in promoting heart disease. We will study this by giving subjects at high risk for heart disease a drug called montelukast which causes leukotrienes to have a reduced effect in the body. In addition for comparison, we will give other subjects a placebo for the same amount of time. These subjects will then be crossed-over and will receive either montelukast or placebo depending on which treatment they received first. We will compare these subjects using blood tests to see if subjects who take montelukast show signs of less inflammation caused by early heart disease as compared to subjects who do not.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Heart Disease

Keywords

coronary heart disease, montelukast, inflammation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

1 lactose-containing capsule daily for 1 month

Arm Title

Montelukast 10 mg

Arm Type

Active Comparator

Arm Description

1 montelukast 10 mg tablet (masked by capsule) daily for 1 month

Intervention Type

Drug

Intervention Name(s)

montelukast

Other Intervention Name(s)

Singulair

Intervention Description

10 mg tablet (masked by capsule) daily for 1 month

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

1 lactose-containing capsule daily for 1 month

Primary Outcome Measure Information:

Title

High-sensitivity C-reactive Protein

Description

measured in a CLIA clinical laboratory facility (Quest Diagnostics, Tampa, FL)

Time Frame

1 month

Secondary Outcome Measure Information:

Title

High Density Lipoprotein (HDL)-Cholesterol

Description

Lipid levels were determined at a clinical laboratory (Quest Diagnostics)

Time Frame

1 month

Other Pre-specified Outcome Measures:

Title

Triglycerides

Description

measured by a clinical laboratory; Quest Laboratories

Time Frame

1 month

Title

Monocyte Chemotactic Protein-1 (MCP-1)

Description

biomarker was measured by enzyme-linked immunosorbant assay (ELISA)

Time Frame

1 month

Title

Interleukin 1 Receptor Antagonist (IL1ra)

Description

IL1ra was determined by enzyme-linked immunosorbant assay (ELISA)

Time Frame

1 month

Title

Epithelial Cell-derived Neutrophil-activating Peptide 78 (ENA-78)

Description

biomarker determined by enzyme-linked immunosorbant assay.

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: -Current hypertension (blood pressure > 140/90 mmHg) or current use of anti-hypertensive medications AND Exclusion Criteria: Current use of lipid-lowering medications Current use of montelukast Poorly controlled hypertension, where systolic blood pressure is greater than 160 or diastolic blood pressure is greater than 100 Use of steroid drugs, non-steroidal anti-inflammatory drugs or other anti-inflammatory medications in the two weeks prior to enrollment. (low dose aspirin ( < 325 mg) is OK, but indication must be cardiovascular) Current recreational drug use Other cardiovascular disease or previous cardiovascular event. These include: history of angina pectoris history of heart failure presence of a cardiac pacemaker history of myocardial infarction previous revascularization procedure history cerebrovascular disease including stroke and transient ischemic attack Pregnancy or lactation Diabetes mellitus Lactose intolerance Contraindications to montelukast therapy Alcoholism Known hepatic disease Existing chronic obstructive pulmonary disease, asthma, allergic rhinitis Active chronic immune, infectious, neoplastic or inflammatory diseases requiring therapy (such as active Hepatitis B, Hepatitis C, human immunodeficiency virus (HIV)) Immunosuppressant therapy or known immunosuppression due to disease high density lipoprotein (HDL) < 40 mg/dL (although this would be a risk factor for heart disease, because of preliminary data which indicates that montelukast may lower HDL levels, we will exclude patients with abnormally low HDL from study) Other criteria at investigator discretion that are deemed to make the subject a poor candidate for the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julie A Johnson, PharmD

Organizational Affiliation

University of Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Florida Family Practice Medical Group Clinic

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32601

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Study of the Arachidonate 5-Lipoxygenase Enzyme in Affecting the Risk for Coronary Heart Disease

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